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Sonio · 18 hours ago

Senior Regulatory Affairs Program Manager (Koren speaking)

Boston, MA

Full-time

Hybrid

Senior Level

6+ years exp

Sonio is a company focused on improving women's and children's health through technological innovation. The role involves developing and executing regulatory strategies for AI/ML-enabled medical devices and serving as a liaison with regulatory bodies like the FDA.

Artificial Intelligence (AI)Health CareHealth DiagnosticsMedical Device

Responsibilities

Develop and implement comprehensive regulatory strategies for AI/ML-enabled medical devices to ensure timely and successful market access

Prepare, compile, and submit high-quality premarket submission files (e.g., 510(k))

Serve as the subject matter expert on FDA regulations and guidance pertinent to AI/ML and software-based medical devices

Act as a primary liaison with the FDA and other regulatory bodies, managing communications and leading negotiations

Monitor the regulatory environment for changes related to SaMD and cybersecurity and assess their impact

Qualification

Regulatory affairs experienceFDA submissionsAI/ML medical devicesRisk management (ISO 14971)Quality management systems (ISO 13485)Total Product Life Cycle (TPLC)Fluency in KoreanFluency in EnglishProject management skillsCommunication skills